1. Field
The invention relates to the placement of catheters in contact with specific anatomical locations while optimizing the direction and orientation of tissue contact.
2. Description of the Related Art
Cardiac rhythm disturbances are a major cause of morbidity and mortality in the adult population. A great deal of progress has been made in the past several decades in the diagnosis and treatment of many of the rhythm disorders of the heart. Intracardiac electrode catheters have been developed for defining the diagnosis of arrhythmias and for delivering ablative energy to specific intracardiac sites. Examples of arrhythmias that are susceptible to treatment with catheter ablation include: atrial fibrillation, atrial flutter, ablation of accessory atrio-ventricular pathways, AV nodal reciprocating tachycardia, ectopic atrial rhythms, ventricular tachycardia arising in either chamber or near the semilunar valves. Because atrial fibrillation is by far the most prevalent significant cardiac arrhythmia in the adult population, and because the ablation of this arrhythmia has become the most common ablation procedure performed in Electrophysiology Laboratories, we will focus our discussion on the putative mechanisms of this arrhythmia and on the various ablation strategies currently utilized for its treatment.
For clinical purposes atrial fibrillation (AF) can be ‘paroxysmal’, ‘persistent’ or ‘chronic.’ Haissaguerre is credited with having made the observation that paroxysmal AF is frequently triggered by a focal ‘trigger’, most frequently in one of the four pulmonary veins that insert into the left atrium. He further reported that ablation of such a trigger can eradicate paroxysmal AF. In patients with persistent or chronic AF, it appears that atrial ‘remodeling’ takes place which somehow augments the number of triggers or ‘drivers’ that initiate and perpetuate AF. In such patients, who, in fact, represent the vast majority of patients presenting with this arrhythmia, the AF ‘drivers’ are probably located further away from the ostia of the pulmonary veins. It is also thought that the autonomic nervous system plays a role in both paroxysmal and persistent AF, and that ablation at or near ganglionic plexi in the left atrium might be effective in the treatment of AF.
With the above observations in mind, empiric sets of RF lesions have been developed during the past several years. Since paroxysmal AF is thought to be trigger-dependent, circumferential lesions around the ostia of pulmonary veins are thought to be an integral part of the ablation procedure. Electrical isolation of the veins is thought to be critical for containment of the triggers within the veins. For patients with persistent of chronic AF, pulmonary vein isolation is usually also performed, but additional lesion sets are also often created so that the AF substrate is drastically modified, including linear sets of lesion across the ‘roof’ of the left atrium connecting the two superior pulmonary veins, as well as an ‘isthmus’ lesion line connecting the left inferior pulmonary vein and the mitral valve annulus. Some physicians also advocate searching for sites in the left atrium which manifest specific electrogram characteristics, such as continuous, low amplitude fragmented signals. Infrequently, the superior vena cava in the right atrium is also electrically isolated, when triggers can be demonstrated to originate from this structure. Finally, in patients who also manifest a typical form of atrial flutter, a line of lesions is often created in the floor of the right atrium, connecting the tricuspid valve annulus to the inferior vena cava.
The foregoing discussion suggests that in order to achieve a therapeutic success with a catheter based ablation procedure, the proper energy source needs to be used, a thorough knowledge of the relevant anatomy needs to be obtained and used during the procedure, the lesions need to be deep enough and sufficiently contiguous in order to prevent electrical conduction at the relevant sites (achieve “isolation” of pulmonary vein ostia), and the catheters need to be able to reach the relevant sites and to remain stable at each site during the delivery of ablative energy.
As noted, in order to safely and effectively perform a left atrial ablation procedure, a detailed understanding of the relevant anatomy is essential. At present, 3D electroanatomic and impedance mapping systems are in use (CARTO, Biosense Webster, and EnSite NavX, St Jude Medical). These systems facilitate the creation of anatomic depictions of the left atrium. Recently, in an attempt to optimize catheter localization, these systems have also evolved to permit the integration of pre-acquired CT and MRI images with real-time 3D maps. One limitation associated with image integration is the potential for chamber wall deformation by catheter pressure on the endocardial surface of the heart; this can result in an inaccurate map and suboptimal image integration. Other limitations of current mapping systems include the occasional creation of anatomic “false spaces”, i.e., computer depiction of regions that do not correspond to true anatomic structures.
The potential for serious complications during and after RF ablation in the heart has been well documented. Adverse outcomes can include tissue perforation with resultant pericardial tamponade and systemic shock, formation of thrombi at the site of ablation or on the tip of the catheter, inadvertent damage to important structures such as coronary arteries or the normal conduction system, late formation (1-2 weeks post-procedure) of an esophageal-left atrial fistula. It is likely that these complications are, at least in part, related to inadequate temperature and energy regulation available in current ablation systems.
As described above, it is common to steer the catheter to a specific position which has been referenced to an anatomical location via an acquired map. The static anatomical maps are used to specify either a median position or extreme limit of the moving tissue surface. Under the rigors of cardiac motion (e.g., the Systole/Diastole cycle), the catheter is guided to the specified surface location by synchronizing the average position of the catheter with the average position of the surface location, represented by a point on the anatomical map.
The prior art has been concerned with the placement of the distal portion of the catheter or medical device with respect to the current location and orientation, or with respect to a location on a static geometric map. The prior art has difficulty in acquiring and maintaining continuous tissue contact in the presence of a dynamic moving frame using static positional reference points. Such reference points, comprising the anatomical map, cannot account for the current location of the actual surface.
Where prior art advances a tool to a geometric location, it cannot specify an optimized tool orientation to acquire and maintain contact with a moving surface.